Full Transcript of Biogen Idec’s 3Q05 Conference Call - Prepared Remarks (BIIB)

| About: Biogen Inc. (BIIB)

Here’s the entire text of the prepared remarks from Biogen Idec’s (ticker: BIIB) Q3 2005 conference call. The Q&A is here. We recognize that this transcript may contain inaccuracies - if you find any, please post a comment below and we’ll incorporate your corrections. And please note: this conference call transcript is a Seeking Alpha product, so feel free to link to it but reproduction is not permitted without the explicit permission of Seeking Alpha.


Elizabeth Woo, VP of IR

Jim Mullen, CEO

Burt Adelman, EVP of Development

Peter Kellogg, CFO and EVP

Bill Rastetter, Executive Chairman


Elise Wang, Citigroup

Robin Karnouskis, Bear Stearns

Joel Sendek, Lazard Capital Markets

Jason Kantor, RBC

Mike King, Rodman Renshaw

Geoff Porges, Sanford Bernstein

Craig Parker, Lehman Brothers

Bill Tanner, Leerink Swann

Eric Schmidt, SG Cowen

May-Kin Ho, Goldman Sachs

Alex Hittle, A.G. Edwards

Mark Karvosky, Piper Jaffray

Kevin Peung, Morgan Stanley

Bret Holley, CIBC World Market


Good afternoon. My name is Ramona, and I will be your conference facilitator. At this time I would like to welcome everyone to the Biogen Idec Third Quarter Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question and answer period. OPERATOR INSTRUCTIONS. I would now like to turn the call over to Ms. Elizabeth Woo, Vice President of Investor Relations.

Elizabeth Woo, VP of IR

Thank you, Ramona. Welcome to Biogen Idec's earning conference call for the third quarter 2005. Before we begin I'd urge everyone to go to the Investor Relations section of our Web site, www.biogenidec.com and printout the press release and accompanying tables. This will make it easier to follow along when our CFO, Peter Kellogg, reviews the financial results and the reconciliation to non-GAAP financial measures discussed today.

I'll start with the Safe Harbor statement. Comments made on this conference call include forward-looking statements regarding the Company's expectations regarding future financial results including the financial objectives of our recent restructuring, the potential for TYSABRI, the short and long-term growth of the Company, plans for the Company's commercial and pipeline products, and plans for external growth and pipeline growth.

Such statements are based on management's current expectations and are subject to risks and uncertainties, which could cause actual results to differ materially. In particular, careful consideration should be given to the risks and uncertainties that are described in our earning release and in the periodic reports Biogen Idec has filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

Today on the call I'm joined by Jim Mullen, CEO of Biogen Idec; Burt Adelman, Executive Vice President for Development; Peter Kellogg, CFO and Executive Vice President, Finance; and Bill Rastetter, Executive Chairman. I now will turn the call over to Jim Mullen.

Jim Mullen, CEO

Thank you, Elizabeth. Good afternoon, everyone. And thank you for joining us. We previously announced our strategic plan to reduce operating expenses to fund increased business development activities in order to accelerate long-term growth. During the quarter, we have progressed against these goals by accomplishing the restructuring and by signing the partnership with PDL to jointly develop and commercialize three phase II antibodies.

Additionally, we achieved several key near term milestones, including completion of the extensive safety evaluation of TYSABRI, the submission of TYSABRI's regulatory filings for multiple sclerosis in the U.S. and Europe, and the submission of RITUXAN's regulatory filings for rheumatoid arthritis in the U.S.

Let me take this opportunity to focus a little more on the details of this restructuring. We believe these initiatives will position the Company for long-term growth and enable us to deliver more for patients, shareholders and employees. Over the years, Biogen Idec has enjoyed many accomplishments. We have pioneered exciting new therapies that have helped paints suffering from MS, cancer, psoriasis, and in the near future, rheumatoid arthritis. We've established an impressive global footprint with strengths in clinical trial design and execution, protein sciences and manufacturing.

We built a world-class commercial organization that can compete and win in specialty markets across the globe, against some of the biggest names in the industry. And we project a solid balance sheet and cash flow over the next few years. In the near term, our core business is strong led by sales of RITUXAN and AVONEX. In addition, our immediate growth prospects are promising, including RITUXAN in RA, TYSABRI in MS, and BG12 for psoriasis in Germany. So again we've accomplished a great deal over the years and our near term fundamentals are strong. We're moving forward more than a dozen candidates in the immunology portfolio and several programs in our oncology pipeline.

As good as we've been in the past and may have been, may be over the next few years, we recognize the need to increase our long-term growth prospects by significantly augmenting the number of programs in our mid- to late-stage pipeline. Over the last few months, we took an extensive look at the state of our business and made several important decisions. We announced in early September Biogen Idec's long-term external growth strategy for the future.

The plan builds upon our near term strengths while driving growth in the midterm and beyond the current decade. The central elements of this initiative are, first, the economic flexibility and more financial discipline, with the purpose, secondly, of reinvesting these savings for accelerated growth through external opportunities. I'll add some detail around both of these points.

So firstly, economic flexibility and more financial discipline. The starting point here is to get leaner and more disciplined. We looked at every activity in the Company and the likelihood that it would create value in the future. What could be consolidated either functionally or geographically, what could be reduced, eliminated, outsourced, or divested.

This analysis resulted in a work force reduction of 17% of our employees worldwide and the planned divestiture of our psoriasis product AMEVIVE, both tough discussions indeed, but these savings will allow for reinvestment in new opportunities. Resizing our work force was the most difficult step, and one we wish we did not have to take. But ultimately it's the right decision if we are to build for the future of our patients, shareholders, and our remaining employees.

Secondly, a decision to accelerate growth through external opportunities. The purpose is to take the money we will save from restructuring and invest in our future by significantly enhancing our pipeline through external collaboration. We expect to be able to earmark approximately $200 million a year for business development and external research opportunities starting in 2006, compared to approximately $50 million earmarked for business development in 2005. Internally this statement brings much greater focus and urgency to accomplishing our business development goals. Externally this is a strong signal to potential partners that we are motivated and have the capacity to execute on opportunities.

We feel that we've begun to execute on this external growth strategy in the third quarter as evidenced by the collaboration we closed with Protein Design Labs that encompass the joint development and joint commercialization of three phase II antibodies. This partnership will expand our oncology presence in solid tumor, while potentially strengthening our position as the leader in the multiple sclerosis research and development. This alliance enables both companies to share costs and risks of developing the products that may address large market opportunities, while leveraging our respective development, manufacturing and commercial strength.

It's our belief that this long-term growth strategy will reposition Biogen Idec to continue to deliver innovative and breakthrough products that will benefit patients as well as billed long-term shareholder value. I'll now turn the call over to Burt Adelman, head of development, Burt?

Burt Adelman, EVP of Development

Thank you, Jim. Good afternoon, everybody. I'm going to take you through a quick trip of our pipeline, starting from our most advanced products with a brief look at some of our earlier products. So let's of course begin with TYSABRI.

As I know you are all aware, we at Biogen Idec and our colleagues at Elan have now completed a rigorous safety evaluation of the majority of the patients who have been exposed to TYSABRI during the development of the product in MS, Crohn's and RA and during the brief period of time it was in the commercial space. Although focused on the incidence of PML, progressive Multifocal Leukoencephalopathy, and other potential complications of immunosuppression, our study was intended to be comprehensive. Today I can say with confidence that we have achieved this objective. Now in summary, we found no new cases of PML, other than those previously reported and no other previously unrecognized pattern of adverse events. These results apply to all patients from all studies, MS, Crohn's and RA.

Now as part of the safety review we assembled an independent adjudication committee sometimes referred to as the IAC, to help us evaluate clinical MRI and laboratory data, and we followed an evaluation protocol that we developed in collaboration with regulatory authorities both in the United States and Europe. Very importantly, we collaborated with the National Institute of Health and the scientists there who have been instrumental in the conduct and interpretation of the JC virus assessments required for these evaluations.

We are uniquely indebted to our colleagues at the NIH, as we are indebted to many other colleagues who have helped over the period of time since we started this evaluation. And we look forward to continued work, both with our colleagues at the NIH and around the world, in continuing to understand the relationship between immunosuppression and the potential risk of PML and other related disorders. Now the complete evaluation, the complete report on these evaluations will be made available, I'm sure, in the near future in the scientific and medical literature.

Now as you also know, the encouraging results of these investigations have enabled us to submit to the FDA on September 26 an sBLA for TYSABRI use in MS. Now a comment on why is this an sBLA rather than simply a request to go back into the commercial space? And it's a very important distinction. This is an sBLA because it contains the final two-year data from the phase III affirmed monotherapy trial. And the SENTINEL add-on trial, in which we compared AVONEX to AVONEX plus TYSABRI. The results of these trials support a request for inclusion of the effect of TYSABRI on the progression of disability.

So in fact we are asking in this sBLA for an expanded label than that which we originally had, so we now want to include the important effects of TYSABRI on preventing the progression of disability in patients with relapsing forms of MS. Also in this sBLA, obviously, is the integrated safety assessment of the patients who were evaluated in this, during this period of time that we've been out of the clinic and a revised label and risk management plan. Now briefly, the purpose of the risk management plan is to ensure, first, that patients and physicians understand the benefits and risks of TYSABRI treatment for MS, and then to ensure that we have a process in place for rapid recognition of any new important safety signals once the product reenters the commercial space.

Now we expect to be informed about the acceptance of the file and whether or not we'll be granted priority review within 60 days after filing, which in this case will bring us towards the end of November. So we await that information from the FDA. At the same time, we are in active conversation with the FDA and European regulatory authorities to initiate redosing of patients with TYSABRI who have MS. And that process is moving along and we should have additional information about that in the not too distant future.

Now just as importantly as our renewed interactions with the FDA with respect to the sBLA, now that we've completed the comprehensive safety evaluation we are again actively working with the CPMP in Europe to continue the review process of TYSABRI there, and things are moving along nicely.

Now from TYSABRI, I'll move to RITUXAN in particular the, actually let me back up for one second, excuse me, and just add one comment on the RA results of TYSABRI. As many of you know we were running a phase II trial with TYSABRI and RA. Although that trial was stopped prematurely, we do believe that enough patients were treated and they were treated for a long enough time for they have to be sufficient data to evaluate the results. And we have concluded that the efficacy results of TYSABRI in RA are inadequate at this time to warrant continued development. So we will present these results in detail at a future medical meeting, but we have made the decision not to continue development of TYSABRI in RA.

Briefly on AVONEX, we are very pleased to see in the July issue of Neurology three important articles in editorial that discuss the importance of neutralizing antibodies in the treatment of patients with MS receiving interferons. Basically the conclusion of these articles in editorial is that neutralizing antibodies are important, that antibody levels tend to remain over time and that patients who have neutralizing antibodies appear to have significantly worse outcomes than those patients without neutralizing antibodies.

Now to move on to RITUXAN, RITUXAN in RA, many of your aware of the successful outcome of the of the REFLEX trial which was the phase III trial of RITUXAN for patients with rheumatoid arthritis who are inadequate responders to anti-TNF therapy. As a result of that trial outcome we did file an sBLA for RITUXAN in this patient population. We filed the sBLA at the end of August, and we'll be awaiting action of the FDA on that. The phase III REFLEX trial results will be presented, I believe, at a plenary session of the American College of Rheumatology in San Diego, I believe on Wednesday, November 16, and we and our colleagues at Genentech will conduct an analyst meeting and conference call at the ACR following the oral presentation of the REFLEX results. So we hope to talk to all of you about that at that time.

The DANCER study, which was the phase IIB study for Demart inadequate responders. As many of you know, it was also successful and we along with our colleagues at Roche and Genentech are preparing to initiate a study program investigating RA, investigating RITUXAN in RA patients who are inadequate responders to Demart therapy. This trial program will be a global program and hopefully will be initiated toward the end of this year or early in 2006. And we continue to be excited about the value of RITUXAN broadly in autoimmune indications and are investigating its use in lupus. There's some clinical trial activities there, and multiple sclerosis and other areas.

Now RITUXAN in oncology, some important news there. We have filed an sBLA for the front, for use of RITUXAN in front line aggressive non-Hodgkin's lymphoma. We filed that in August, the FDA has granted priority review status. We are obviously pleased by that because the assignment of priority review status demonstrates to us that the FDA recognizes the significant improvement in survival RITUXAN may offer patients with aggressive forms of lymphoma.

We also anticipate filing the combined RITUXAN indolent frontline and maintenance sBLA in the first half of '06. Also on RITUXAN in oncology, our colleagues at Roche recently announced important new maintenance data in indolent non-Hodgkin's lymphoma from the European Organization For Research and Treatment of Cancer study. I'm not going to go through the results here, but I will tell you that they have been accepted for presentation at the American Society of Hematology meeting this December, which I guess has been moved from New Orleans to Atlanta, so we all look forward to hearing those results there. Not too long from now.

We're continuing our efforts in chronic Lymphocytic Leukemia with RITUXAN in U.S. and Europe. A quick note on ZEVALIN, we have submitted to the FDA our protocol for incorporating ZEVALIN into the treatment of patients with diffuse large B-cells lymphoma, high-grade lymphoma, and we hope to initiate that study early in 2006. That study is being conducted around the world in collaboration with our ZEVALIN partner, Schering AG.

The fumarate program, BG12, PANACLAR, as we've said in the past we have submitted that product to the German regulatory authorities for use, approval for use in psoriasis. It is under review. And we hope to hear sometime early in '06. Similarly, we are completing a comprehensive phase II MS study, and we'll have a view on the further development of PANACLAR in MS also some time early in '06. So stay tuned, we're obviously very excited about the BG12 program and the upcoming results.

With respect to our early pipeline, we've continued to move programs ahead in neurology, autoimmune disease and oncology. We filed an IND in the third quarter for Lymphotoxin beta inhibition in rheumatoid arthritis in Demart inadequate responders. We expect to initiate phase II by year-end. Our small molecule phase II program in Parkinson's disease with our colleagues at Vernalis should be, begin accruing patients early until '06. A number of our oncology programs are moving along in phase I trials. Our anti-Lymphotoxin beta receptor program, CB11, is accruing patients.

Our gene therapy adenovirus delivery of interferon beta is ongoing in an IV infusion study for patients with colorectal cancer, and we have a exciting collaborative study with investigators at the University of Pennsylvania looking at the use of that agent in patients with metastatic pleural effusions. And internally, we are assessing our development plans for our anti-CD23 program in chronic lymphocytic leukemia and for the possibility of moving our anti-CD80 program forward into phase III in patients with non-Hodgkin's lymphoma.

Just to emphasize the point that Jim has already made, we are very excited about our collaboration with PDL. It is certainly one of the more exciting recent collaborations in biotechnology. It covers a spectrum of products in autoimmune and oncology areas, areas of great interest and expertise of both Biogen and PDL, and we are moving forward with all of these programs, Daclizumab, the antibody to IL2 is ongoing in multiple sclerosis.

The M200 antibody, an anti-angiogenic agent, is moving forward in a number of solid tumor indications, and the HuZAF, humanized antibody that targets gamma interferons, is being investigated across a number of potential autoimmune indications. So we hope that this multi-product relationship with PDL will be the first of a number of similar programs that we are able to conclude in the next year through our very active BD efforts. So thanks for your attention, and I'll now hand the call over to Peter.

Peter Kellogg, CFO and EVP

Thank you, Burt. Before I move on to the financials let me remind everyone that since the Biogen Idec merger in the fourth quarter of 2003, we have provided table three on our earning release as a reconciliation of the GAAP to non-GAAP financial results. As I view the P&L operating performance of Biogen Idec, the bridging items that reconcile GAAP versus non-GAAP are listed in this table three, and these will allow you to follow the non-GAAP performance.

The main items excluded from operating non-GAAP this quarter are purchase accounting charges, as usual, of $88 million due to the quarterly purchase accounting impact on cost of sales and amortization of intangibles. Secondly, severance and restructuring charges of $27 million due to the reduction in force and strategic changes announced in September. And thirdly, impairment and loss on the sale of assets of $21 million driven primarily by the classifications of our NICO clinical manufacturing plant as an asset held for sale and marked down to its appraised value. And additionally some related residual costs from the sale of the NIMO manufacturing plant.

Now because staff restructuring and asset disposals are non-operating, we have adjusted these charges from our non-GAAP P&L along with other normal purchase accounting elements. Accordingly our non-GAAP EPS was $0.36 per share for the Q3. We have included a number of charges in our non-GAAP P&L this quarter since they are operational in nature. Included in the non-GAAP P&L this quarter are the following charges. $50 million in R&D associated with a $40 million up front payment to PDL, as well as $10 million in future payments; a $25 million operating charge due to ZEVALIN intangibles and inventory impairment which is broken out between cost of sales and SG&A which a I'll discuss later. This is based on our annual long-range plan reevaluation of ZEVALIN expectations; and lastly, a $5 million write down of securities associated with Sunesis.

Now I'd like to walk through the P&L line, beginning with our third quarter total revenue, which was $596 million, a 10% revenue growth over the same period last year. Now some of you may notice that revenue was down quarter-over-quarter, and I'd like to point out that Q3 revenue was higher than all previous quarters except for Q2 and we feel that Q2 was simply an exceptional quarter all around.

And the main driver for the drop in revenue quarter-over-quarter was AVONEX International, which I will address in more detail in a minute. However, as you will see, the underlying business trends across the line are positive and very solid. Now going through our product revenues beginning with AVONEX, the number one MS product worldwide, our third quarter worldwide product sales were $375 million, an 8% increase year-over-year. In the U.S., the third quarter product sales for AVONEX were $235 million, up 5%. And the U.S. AVONEX remains the market leader with about 40% market share in the MS market.

On the international front, AVONEX in the third quarter had product sales of $140 million, up 15% versus prior year. Now on a year-over-year basis, AVONEX's Q3 sales growth in local currency was 13%. The foreign exchange impact in Q3 was roughly $3 million, or contributed about two points of growth. Now on a quarter-over-quarter basis, as I mentioned earlier, a few unusual items affected sequential quarterly growth. First, Germany, our largest market, had a softer quarter, in part due to some stronger Q2 sales that we now believe may have been driven by a price increase taken in May. Secondly, as you are aware, the Euro actually softened in Q3 versus the dollar causing a $5 million down side based on currency versus the prior quarter. Now remember, although ForEx helped on a year-over-year basis, on a quarter-over-quarter basis the impact was negative.

Finally our business model in Italy changed from a distributor to a consolidated joint venture. Which changes revenue recognition from a sell-in structure to a sell-through model. This results in a delay of revenue recognition on a one-time basis for certain units held by the distributor until they've been sold through the distributor to the market, creating a one-time softening of reported sales.

However, stepping back from all of this, perhaps the most important message throughout is that AVONEX continues to be the most used international MS therapy based on patient share. We estimate our worldwide market share to be in the low 30s with Rebif and Betaseron following closely behind. In addition, we continue to gain market share internationally and are growing slightly faster than the total MS market, which indicates clearly that the business is very strong and doing quite well.

Now moving down the P&L, in the third quarter, AMEVIVE product sales were $12 million. In the third quarter ZEVALIN product sales were $5 million. And royalties in the third quarter were $23 million. Our RITUXAN collaboration revenues come next, which is titled revenue from unconsolidated joint business. And that was $182 million, an increase of 14% year-over-year. As we always discuss, this number has several elements.

First we receive our share of the U.S. RITUXAN profits. U.S. RITUXAN sales were $456 million in the third quarter, and our Q3 profit share from that business was $129 million, up 9% versus prior year. In Q3, although U.S. RITUXAN revenue was up 16% year-over-year, this was somewhat offset by increased costs for regulatory filings and initial build up of the collaboration's R&D commercial infrastructure.

Now secondly, we receive royalty revenue on sales of Rituximab outside the U.S. and in Q3 this was $42 million, up 28% versus prior year driven by the impressive growth of MabThera internationally. And third, we were reimbursed for selling and development costs incurred related to RITUXAN. This was $11 million in Q3.

Now turning to the expense lines on the P&L, in Q3 our adjusted cost of sales were $78 million, and that's about 13% of revenues. Now the reason why cost of sales are slightly higher in Q3 is because of some ZEVALIN impairment charges that I mentioned earlier. Let's discuss this. Each year, our long-range plan reevaluates our portfolio of products. This year's analysis resulted in near term reduced expectations for ZEVALIN, resulting in a $25 million charge due to the impairment of ZEVALIN inventory and intangibles. This charge is split between cost of sales and SG&A. There'll be about $12 million charge if its imbedded in the numbers for cost of sales and about $13 million charge imbedded in the numbers for SG&A.

I would like to point out, however, that although ZEVALIN's growth expectations in the near future have declined, we are still interested in ZEVALIN's long-term potential as a consolidation therapy in the diffuse large B-cell lymphoma market, as Burt mentioned earlier, which is a longer term future growth driver, perhaps, for the Company.

In the third quarter, R&D was $207 million, 35% of revenue. Now the R&D charges in Q3 did include the $50 million due to the PDL collaboration. And as I mentioned earlier, this includes the up-front of $40 million and future payment liabilities totaling $10 million that were booked in Q3 because of the future certainty of these payments. I'd also like to note that we had $10 million of TYSABRI high titre development and production expenses in Q3. Now, only 1 million of this amount was for normal TYSABRI production. 9 million was related to high titre development work that would normally be charged to R&D anyway, so this is not really an unusual charge for Q3 in any way.

Our third quarter SG&A was $154 million, 26% of revenue, and as I just finished mentioning, that includes $13 million of the impairment of ZEVALIN intangibles. The Q3 OIE was $11 million, and this includes a $5 million write down of marketable securities for Sunesis stock.

Our third quarter tax rate was 27%. Now, on a tax basis the significant charges incurred for the PDL deal and restructuring caused our income in the U.S. to be much lower, driving our worldwide tax rate down for the quarter. This brings our year-to-date tax rate to approximately 30%, which is the rate we anticipate for the full year. These tax rate impacts are temporary for 2005, and we expect the tax rate in 2006 to return to the low 30s in terms of percent. In the third quarter, diluted share outstanding that we use for non-GAAP EPS calculations were 344 million shares. So this brings us to our Q3 adjusted EPS of $0.36 per share.

Now, I'd like to touch on a couple of final topics. Clearly, this has been a year full of events that created numerous accounting impacts. Given all these events, however, we thought it was important to remind you that we expect 2006 will be quite different. As we look ahead to 2006, we expect and have modeled that first TYSABRI will be reintroduced in the U.S. in mid 2006 and launched in the EU in the second half of 2006.

We are assuming TYSABRI will be a modest contributor to 2006 revenue. Remember, the U.S. revenue per unit for Biogen Idec is based on the transfer price to Elan while the EU revenue per unit is at market. Also, we do not expect to have any cost of sales in 2006 based on the inventory write off taken in 2005. This will improve the overall Biogen Idec gross margin in 2006.

Now secondly, we've assumed that RITUXAN in RA will be approved and launched by mid 2006 as well. All other lines in the P&L are expected to remain consistent with current trends and that leads us to having operating expense that we would expect to be in the range of $1.4 billion to $1.5 billion, which includes $200 million allocated to business development as well as flow through expenses from the PDL deal. Biogen Idec intends to spend the full $200 million in 2006 on BD activities, but, of course, it is hard to predict the timing of that spend.

Fourthly, we expect our tax rate to remain approximately in the low 30% range, as I mentioned earlier, and finally, as a result of these assumptions we are estimating 2006 EPS to be in the range of $1.95 to $2.10. We are not giving detailed line by line guidance due to the number of moving parts in 2006, which I'm sure you can all well appreciate. Please note that these estimates do not include the impact of FAS 123 R because we are still evaluating our long-term incentive program. I will provide an update on this during our fourth quarter earnings call. Also, we anticipate capital spending in 2006 to be much lower than this year. We expect it to be in the range of $200 million to $275 million.

So in summary, Q3 was a complex quarter where the Company has taken several bold decisions to redirect our future. These actions triggered a number of charges from a financial standpoint, but we feel that our decisions position us well to achieve our 2006 goals and beyond. The core businesses of Biogen Idec, AVONEX and RITUXAN, are strong. We expect TYSABRI to be a future contributor to our growth as well, as we build the next stage of the Company. Now I'd like to hand off to Bill Rastetter for his closing comments, Bill?

Bill Rastetter, Executive Chairman

Thanks, Peter. Before we go to your questions I'd like to close on behalf of the entire team at Biogen Idec. The thrust of our restructuring initiative is to plan for the future by reinvesting the money we will save to expand our pipeline, capitalizing both on internal and external opportunities. What does success look like several years out, say in the 2010 to 2012 time frame? Let me walk you through a brief glimpse of where we hope to go.

We expect to continue to be a global leader in neurology in general and MS in particular. We expect that TYSABRI, with its strong efficacy profile, will be available as an important treatment option for patients. We also hope to be on the brink of delivering a broad range of MS therapies to patients, including RITUXAN, Daclizumab, which you will recall we recently partnered as a part of the PDL deal, and the oral product, BG12. Further backing development, we hope to have made considerable progress on the Nogo program for nerve regeneration, and the LINGO program for remyelination. Both of these proteins offer significant promise to patients in potentially reversing the course of their disease.

In addition to MS, we hope to have made considerable progress in other areas of neurology. There is considerable unmet need in Parkinson's disease, Alzheimer's disease, stroke and neuropathic pain. In oncology, we see a market crowded with significant competition, but also one in which the unmet need for patients is truly staggering. It is our goal to make the leap from being a top U.S. company in hematologic tumors to being viewed as a true global leader in oncology across the board from discovery to development to commercialization. Oncology is an outstanding test for our culture of collaboration. While success here involves moving our internal programs along, we must also grow and build through external partnerships.

A focus for '06 will be expanding our oncology R&D efforts, attracting top talent, developing early stage partnerships with academic centers, entering R&D collaborations with other companies, building opportunities in the solid tumor market and expanding our pipeline to include small molecules.

We will remain open as well to expanding into other major therapeutic areas. Here, we'll stay focused on discovering, developing and commercializing significant products against high unmet medical need for global specialty markets. These may include rheumatoid arthritis. This is certainly an area where we hope to be a player. We're obviously making good strides with RITUXAN, lupus, Crohn's disease and ulcerative colitis. As a result of our efforts to collaborate at all levels of our pipeline, we will expect to see a doubling of products progressing through our pipeline in the 2010 to 2012 time frame, a vast network of research collaborations, what we call collaborative inquiring with top academic, government, teaching hospital, and bio tech and pharmaceutical companies, both in the U.S. and across Europe. Our restructuring initiative was a first step towards achieving this vision for the 2010, 2012 period. Now I'll turn the floor back to Elizabeth for your questions.

Elizabeth Woo

Operator, we are ready to take questions.

Question-and-Answer Session



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